Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

The primary study outcome is death from all causes at 90 days after randomisation.

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Timepoint [1]1860

Every randomised patient will be followed up until either death or 90 days post-randomisation as recommended by the UK Medical Research Council International Working Party for Clinical Trials in Patients with Sepsis and Septic Shock.

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Secondary outcome [1]4160

Death in the intensive care unit.

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Timepoint [1]4160

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Secondary outcome [2]4170

Death within 28 days of randomisation.

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Timepoint [2]4170

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Secondary outcome [3]4180

Death prior to hospital discharge.

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Timepoint [3]4180

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Secondary outcome [4]4190

Length of ICU stay.

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Timepoint [4]4190

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Secondary outcome [5]4200

Length of hospital stay.

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Timepoint [5]4200

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Secondary outcome [6]4210

The need for and duration of other organ support (inotropic/vasopressor support and positive pressure ventilation).

1. Patient age is <18 years. 2. Death is imminent (<24 hours). 3. There is a strong likelihood that the study treatment would not be continued in accordance with the study protocol. 4. The patient has been treated with CRRT or other dialysis previously during the same hospital admission. 5. The patient was on maintenance dialysis prior to the current hospitalization. 6. The patients body weight is <60kg or >100kg. 7. Any other major illness that, in the investigators judgment, will substantially increase the risk associated with the subjects participation in this study.

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Study design

Purpose of the study

Treatment

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Allocation to intervention

Randomised controlled trial

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Procedure for enrolling a subject and allocating the treatment (allocation concealment
procedures)

Central randomisation via telephone

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Methods used to generate the sequence in which subjects will be randomised (sequence
generation)

Computer generated using minimisation - stratified according to study centre

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Masking / blinding

Open (masking not used)

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Who is / are masked / blinded?

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Intervention assignment

Parallel

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Other design features

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Phase

Phase 4

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Type of endpoint(s)

Pharmacokinetics

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Statistical methods / analysis

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Recruitment

Recruitment status

Not yet recruiting

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Date of first participant enrolment

Anticipated

1/11/2005

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Actual

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Date of last participant enrolment

Anticipated

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Actual

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Date of last data collection

Anticipated

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Actual

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Sample size

Target

1500

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Accrual to date

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Final

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Recruitment in Australia

Recruitment state(s)

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Funding & Sponsors

Funding source category [1]2020

Government body

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Name [1]2020

NHMRC

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Address [1]2020

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Country [1]2020

Australia

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Primary sponsor type

Other

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Name

The George Institute

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Address

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Country

Australia

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Secondary sponsor category [1]1510

None

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Name [1]1510

None

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Address [1]1510

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Country [1]1510

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Ethics approval

Ethics application status

Approved

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Ethics committee name [1]9650

Austin Hospital,

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Ethics committee address [1]9650

Heidelberg, VIC 3084

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Ethics committee country [1]9650

Australia

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Date submitted for ethics approval [1]9650

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Approval date [1]9650

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Ethics approval number [1]9650

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Summary

Brief summary

Patients who have developed kidney failure in the intensive care unit (ICU) ar being invited to take part in a clinical research study comparing two different types of artifical kidney treatment, which doctors call continuous renal replacement therapy or CRRT for short. The goal of the study is to compare two doses of CRRT. This treatment is also commonly known as continuous dialysis. As it stands doctors are uncertain as to the best level of intensity of treatment with a kidney machine in this setting and wish to do a study comparing two levels of treatment to see which one is best for patients with this condition.If a patient has acute renal failure and they require treatmnet they will still receive one of these treatments because their kidneys are failing.The CRRT two doses are: 1. Continuous renal replacement therapy at 40 ml/kg/hr (about 3 litres per hour) of fluid exchange or 2. Continuous renal replacement therapy at 25 ml/kg/hr (about 2 litres per hour) of fluid exchange. This study will involve 1500 patients from 30 Intensive Care Units in Australia and New Zealand and will include all types of patients admitted to Intensive Care.

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Trial website

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Trial related presentations / publications

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Public notes

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Contacts

Principal investigator

Name
362860

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Address
362860

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Country
362860

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Phone
362860

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Fax
362860

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Email
362860

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Contact person for public queries

Name
92380

Dr David Ali - Senior Project Manager - RENAL STUDY

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Address
92380

The George Institute for International HealthKing George V BuildingLevel 10 Royal Prince Alfred HospitalMissenden RoadCamperdown Sydney NSW 2050